HOW ISO-15189 LABORATORY ACCREDITATION ASSURES PATIENT SAFETY?

Abstract

Healthcare is a complex profession involving the state-of-art technology and sometimes leading to unintentional harm. Many factors contribute to the occurrence of medical errors. Patient safety is one of the most serious global health issues and defined as the absence of preventable harm to a patient during any process of medical care. The frequency of medical errors is higher than expected. It has been concluded that the majority of medical errors are not because of the individual attitudes but mainly caused by faulty systems or processes leading the staff to make mistakes or fail to prevent them. Patient safety is a shared responsibility comprised of many stakeholders such as society, patients, nurses, educators, administrators, researchers, physicians, government and legislative bodies, professional associations and accrediting agencies. Medical laboratory services are essential to patient care and need to be available to meet the needs of both patients and caregivers. ISO-15189:2007 Medical Laboratories-Particular requirements for quality and competence, an internationally recognized standard containing requirements necessary for diagnostic laboratories to demonstrate their competence to deliver reliable laboratory services. It applies quality system requirements to the clinical laboratories with a strong focus on responsiveness to the needs of patients and clinicians. Applying the performance improvement strategies focusing on different phases in total testing process will significantly reduce the errors and therefore will improve the patient safety. In this way, laboratory professionals contribute to improvement of safety and outcomes of care by working in interdisciplinary approach manner.